MAUDE Adverse Event Report: OSTA ROTATING CF RESECTOSCOPE INNER SHEATH; ROTATING CONT. FLOW INNER SHEATH

Model Number ERIS-CF25

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.The most likely cause for this type of sheath damage can be attributed to excessive pressure applied during the procedure.The instruction manual warns users: "always keep sheaths parallel to one another when assembling and disassembling.If the inner sheath is inserted or removed at an angle to the outer sheath, the lateral force applied to the inner sheath may crack, loosen, break, or otherwise damage the sheath's insulated distal tip.".

Event Description

Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the sheath was inserted into the bladder and the entire ceramic tip came off the end.The device fragment was retrieved using a flexible grasper.The procedure was prolonged approximately 10 minutes due to foreign body removal.The intended procedure was completed.There was no patient injury reported.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: ROTATING CONT. FLOW INNER SHEATH
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 5972659
• MDR Text Key: 55437427
• Report Number: 2951238-2016-00758
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERIS-CF25
• Device Catalogue Number: ERIS-CF25
• Device Lot Number: N/A
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1